Stopped: amendment to be done, adding 200 patients
Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Considering that the calculated bio-equivalent doses to the tumor are similar for all treatment options, the UHF technique is deemed to be non-inferior to the standard approach. Treatment acceptability, tolerance and adverse events will be reported and compared for non-inferiority as the primary objective. Secondary objectives are biochemical control, metastasis-free, disease specific and overall survival.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Non-inferiority analysis of early change in genito-urinary (GU) toxicities induced.
Timeframe: Every 3 months for 1 year.
Non-inferiority analysis of early change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.
Timeframe: Every 3 months for 1 year.
Non-inferiority analysis of late change in genito-urinary (GU) toxicities induced.
Timeframe: Every 6 months up to 36 months, then annually up to 10 years.
Non-inferiority analysis of late change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.
Timeframe: Every 6 months up to 36 months, then annually up to 10 years.
Non-inferiority analysis of early change in sexual health.
Timeframe: Every 3 months for 1 year.
Non-inferiority analysis of late change in sexual health.
Timeframe: Every 6 months up to 36 months, then annually up to 10 years.
Non-inferiority analysis of early change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).
Timeframe: Every 3 months for 1 year.
Non-inferiority analysis of late change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).
Timeframe: Every 6 months up to 36 months, then annually up to 10 years.